The Technical Operations Engineer plays a critical role in ensuring reliable product supply and quality for externally manufactured pharmaceutical products. This position involves overseeing technical operations activities, including technology transfers, process validation, product investigations, and new product launches. The role requires collaboration across multiple departments, such as Business Development, Quality, and R&D, and focuses on oral solid-dose, liquid, and sterile injectable formulations. Experience with combination products and knowledge of Design Controls and DHF development are advantageous.
Responsibilities
- Lead Technology Transfers & New Product Launches: Manage product technology transfer and ensure readiness for new product introductions (40%).
- Technical Assessments & Improvements: Execute product-specific technical evaluations, troubleshoot issues, and drive problem resolution (20%).
- Document Review & Approval: Prepare, review, and approve technical documents (e.g., validation protocols, change controls, FMEAs, cleaning validations) (25%).
- Process Capability Improvements: Identify opportunities to enhance manufacturing processes and product quality (5%).
- Manage Change Controls, Complaints, & Investigations: Conduct technical analysis of product complaints, recommend CAPAs, and provide impact assessments for change controls (10%).
Qualifications
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Education: BS in Chemical Engineering, Chemistry, Pharmacy, or a related field with 7+ years of pharmaceutical industry experience, or an advanced degree with 5+ years of experience.
- Technical Expertise: Familiarity with cGMP, FDA regulations, SUPAC, and ICH guidelines. Strong understanding of pharmaceutical manufacturing processes and equipment.
- Desirable Experience: Knowledge of aseptic (sterile) manufacturing, various dosage forms, and formulation development.
- Collaborative Skills: Proven ability to work with CMOs, external vendors, and cross-functional teams in a matrix organisation.
Skills & Abilities
- Analytical and problem-solving expertise for technical issues.
- Strong decision-making and independent action capabilities, with an awareness of broader business impacts.
- Knowledge of pharmaceutical technologies, manufacturing equipment, and validation requirements.
Physical Requirements
- Ability to travel up to 25%.
This role offers a dynamic and challenging opportunity to lead critical technical projects and support product lifecycle activities in a fast-paced environment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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